ACUITY (Acute Catheterization and Urgent InterventionTriage Strategy)GW Stone (Columbia University Medical Center Cardiovascular Research Foundation, NY)American College of Cardiology 2006 Scientific Sessions• Population and treatment: 13 819 patients with moderate- to high-risk ACS who all underwent cardiac catheterization within 72 hours + percutaneous or surgical revascularization when appropriate Patients randomized to: UFH or enoxaparin plus routine GP IIb/IIIa inhibition; bivalirudin plus routine GP IIb/IIIa inhibition; or bivalirudin alone, with GP IIb/IIIa inhibition only given as bailout• Primary outcome: Composite of death, MI, unplanned revascularization for ischemia, and major bleeding at 30 days
ACUITY: Results• Significantly less bleeding than and a similar rate of ischemic events with bivalirudin vs UFH or enoxaparin + a GP IIb/IIIa blocker–a benefit that is lost when bivalirudin is combined with a GP IIb/IIIa blockerPrimary end point at 30 days End point UFH/enoxaparin Bivalirudin alone pa Bivalirudin pb + GP IIb/IIIa (n=4612), % + GP IIb/IIIa blocker blocker (n=4603), % (n=4604), % Non- Superiority Non- Superiority inferiority inferiority Death/MI/unplanned 11.7 10.1 0.0001 0.015 11.8 0.0001 0.93 revascularization/major bleeding Death/MI/unplanned 7.3 7.8 0.011 0.32 7.7 0.07 0.39 revascularization Major bleeding 5.7 3.0 0.0001 0.0001 5.3 0.0001 0.38a. For UFH/enoxaparin + GP IIb/IIIa blocker vs bivalirudin aloneb. For UFH/enoxaparin + GP IIb/IIIa blocker vs bivalirudin + GP IIb/IIIa blocker
ACUITY: Commentary*"This is a very complicated trial . . . To make recommendations on these results,we need to take a detailed look at the data, which has not been possible so far." - Dr Paul Armstrong"The biggest issue for me about this trial is that they used a control group that is ablended mix of therapies. . . . We go to the cath lab fast with [ACS] patients, andyou need at least two doses of enoxaparin to get maximum therapeutic efficacy;there may not be time for that. I want to know how bivalirudin compares withunfractionated heparin without the enoxaparin patients included." - Dr Dan Simon*All comments from ACUITY: Bivalirudin preferential to heparin plus GP IIb/IIIa blocker in ACS patientsheading to the cath lab early (http://www.theheart.org/article/663535.do)
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